Registration Dossier
Registration Dossier
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EC number: 227-999-8 | CAS number: 6065-82-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 12 March 1992 to 28 April 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP guideline study with deviations: only one animal tested (absence of ocular irritation potential not confirmed with additional animals), and the same animal was used 7 days earlier for the skin irritation test. The study report contains only limited descriptions on study design, housing conditions and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- described in the directive 84/449/CEE
- Deviations:
- yes
- Remarks:
- only one animal tested, and the same animal was tested 7 days earlier for skin irritation
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl diethoxyacetate
- EC Number:
- 227-999-8
- EC Name:
- Ethyl diethoxyacetate
- Cas Number:
- 6065-82-3
- Molecular formula:
- C8H16O4
- IUPAC Name:
- ethyl 2,2-diethoxy-acetate
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole of Val de Selle
- Age at study initiation: no data
- Weight at study initiation: 3.5 kg
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: nothing reported in the study report. Assumed to be the untreated right eye.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL unchanged - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours after instillation of the test material.
- Number of animals or in vitro replicates:
- 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Mode of administration: 0.1 mL of the test material was introduced into the conjunctival sac of the left eye of the female rabbit.
- Washing: no washing performed
- Time after start of exposure: no data
SCORING SYSTEM: no data (assumed to be that described in directive 84/449/CEE)
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- only one treated animal
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- only one treated animal
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- other: 1 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cornea opacity observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one treated animal
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cornea opacity observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cornea opacity observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cornea opacity observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- other: 1 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no reaction observed
- Irritant / corrosive response data:
- 1 hour after the instillation of the test material, slight chemosis and redness of conjunctivae (score of 1) were observed. No reaction was observed in iris and no corneal opacification was noted.
After 24 hours, the conjunctival reactions were fully reversed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: based on the observed data
- Conclusions:
- Under the experimental conditions of this test, the test material was considered non irritant to the rabbit eye.
- Executive summary:
This non-GLP-compliant study was performed to assess the potential of the test material to induce eye irritation in vivo, according to the EU method B5 described in annex V of the 84/449/CEE directive.
Material and methods
0.1 mL of the test material were introduced as supplied into the conjunctival sac of the left eye of one female rabbit without washing.
The ocular reactions were recorded 1 hour, 24, 48 and 72 hours after the instillation of the test material.
Results
1 hour after the instillation of the test material, slight chemosis and redness of the conjunctivae (score of 1) were observed. No reaction was observed in iris and no corneal opacification was noted.
After 24 hours, the conjunctival reactions were fully reversed.
Conclusion
Under the experimental conditions of this test, the test material was considered non-irritant to the rabbit eye.
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